ADDITIVE CAP


Device Classification Name

container, i.v.

510(k) Number K111217
Device Name ADDITIVE CAP
Applicant
BAXTER HEALTHCARE CORP.
1620 waulkegan rd.
mcgaw park, 
IL 
60085 -6730

Applicant Contact nanette hedden
Correspondent
BAXTER HEALTHCARE CORP.
1620 waulkegan rd.
mcgaw park, 
IL 
60085 -6730

Correspodent Contact nanette hedden
Regulation Number 880.5025
Classification Product Code
KPE  
Date Received 05/02/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No